Quality of Life Study in Adults With Facial Eczema

• ClinicalTrials.gov Identifier: NCT00120302
• Recruitment Status: Completed
• First Posted: July 15, 2005
• Last Update Posted: January 17, 2008
• Sponsor: Novartis
• Information provided by: Novartis

Tracking Information

• First Submitted Date: July 8, 2005
• First Posted Date: July 15, 2005
• Last Update Posted Date: January 17, 2008
• Study Start Date: March 2005
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures (submitted: September 6, 2006): Change in quality of life score between baseline (study start) and week 4.
• Original Primary Outcome Measures: Not Provided

Current Secondary Outcome Measures (submitted: September 6, 2006)

• Changes in patient's quality of life from baseline (study start) to 1 and 2 weeks after the beginning of treatment.
• Between-treatment comparison of Investigator's Global Assessment (IGA) (face only); Patient's Global Assessment (face only); Pruritus (itch) Severity Assessment (face only).
• Time from baseline (study start) to clearance of eczema.

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Quality of Life Study in Adults With Facial Eczema
• Official Title: Quality of Life Study in Adults With Facial Eczema

Brief Summary

This study is not being conducted in the US.

The study consists of a 4 week double blind treatment period. All patients meeting the inclusion/exclusion criteria will enter the study at day 0 and be randomized into either pimecrolimus cream 1% or vehicle treatment groups in a 1:1 ratio. Patients will return to clinic on days 7,14 and 28 for assessments of disease severity. Patients who experience an unsatisfactory therapeutic effect, will attend an unscheduled visit and be withdrawn from the study.

Assessments of eligibility include an Investigator's Global Assessment and Pruritus score. Treatment history will be collected at baseline and Quality of Life Questionnaires will be carried out at every visit.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Atopic Dermatitis

Intervention

• Drug: Pimecrolimus
  Pimecrolimus cream 1 %
  Other Name: Elidel
• Drug: Placebo
  Matching vehicle cream

Study Arms

• Experimental: 1
  Pimecrolimus
  Intervention: Drug: Pimecrolimus
• Placebo Comparator: 2
  Vehicle
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 15, 2008): 76
• Original Enrollment: Not Provided
• Actual Study Completion Date: January 2006
• Primary Completion Date: Not Provided

Eligibility Criteria

Inclusion Criteria:

• Males and females aged 18 years or older
• Active Moderate Facial AE at baseline (Facial IGA score of 3), within 3 days of a deterioration in symptoms that necessitates further treatment.

• Diagnosis of AE fulfilling the diagnostic criteria of Williams (Williams, et al. 1994) outlined below: *Must have an itchy skin condition plus 3 or more of the following 5 items listed below:

  1. History of involvement of the skin creases such as folds or elbows, behind the knees, fronts of ankles or around the neck;
  2. A personal history of asthma or hay fever;
  3. A history of a general dry skin in the last year;
  4. Visible flexural edema;
  5. Onset under the age of 2
• Pruritus score of 2 or above at baseline

• Patients in whom further use of TCS is clinically inappropriate due to:

  • burning, stinging, allergic reaction or other adverse event that prevents the patient from using topical corticosteroids to successfully treat an AE flare on the face;
  • presence of rosacea, telangiectasia, skin atrophy or glaucoma as a result of topical corticosteroid usage on the face;
  • presence of AE on the eyelids Or patients where previous treatment has been unsatisfactory and who would prefer to try an alternative treatment option.
• Patients who have been informed of the study procedures and have signed the informed consent form approved for the study. (Informed consent should be signed as instructed in ICH-GCP and local regulations).

Exclusion Criteria:

At baseline and throughout the study, females of childbearing potential:

• Who are pregnant or breast-feeding
• Who are menstruating, capable of becoming pregnant, and not practicing a medically approved method of contraception during and up to at least 4 weeks after the end of study treatment. A negative pregnancy test (urine) for all females of childbearing potential is required at the screening visit. 'Medically approved' contraception may include abstinence at the discretion of the investigator

At baseline and throughout the study, all patients:

• Who have received phototherapy (e.g. UVB, UVA) or systemic therapy (e.g. immunosuppressants, cytostatics) known or suspected to have an effect on AE within 1 month of Visit 1 (baseline)
• Who have received systemic corticosteroids (e.g. oral, intravenous, intra-articular, rectal) within 1 month of Visit 1. Patients on a stable maintenance dose of inhaled corticosteroids may participate
• Who have a known or suspected contact allergic dermatitis
• Who have received systemic antibiotics within 2 weeks prior to Visit 1.
• Who have used oral or topical antihistamines for the treatment of Pruritus within 2 weeks prior to visit 1
• Who have applied topical therapy (e.g. tar, topical corticosteroids, pimecrolimus or tacrolimus within 2 weeks prior to Screening
• Who have used potent or very potent TCS within 4 weeks prior to Visit 1.
• Who are immunocompromised (e.g. lymphoma, HIV infection/AIDS, Wiskott-Aldrich Syndrome) or have a history of malignant disease
• Who have a history of poor or no clinical response, or hypersensitivity to topical pimecrolimus cream 1%.
• Who have concurrent skin disease (e.g. acne) of such severity in the study area that it could interfere with the evaluation.
• Who have active bacterial (e.g. impetigo), viral (e.g. chicken pox, herpes simplex) or fungal infections (e.g. tinea corporis, intertriginosa)
• Who have received any investigational drugs within 8 weeks of visit 1, or plan to use any other investigational drugs during the course of this study
• Who, in the opinion of the investigator, are known to be unreliable, who are non-compliant with medical treatment, or are known to miss appointments
• Who have abuse problems, mental dysfunction or other factors limiting their ability to cooperate fully in study-related procedures

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT00120302
• Other Study ID Numbers: CASM981CGB02
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: External Affairs, Novartis
• Original Responsible Party: Not Provided
• Current Study Sponsor: Novartis
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Chair: Novartis; Novartis

• PRS Account: Novartis
• Verification Date: January 2008